FDAFDA · Food and drugs·Recall number Z-0682-2019
ABL800 analyzer, model numbers 393-800 and 393-801.
Published January 2, 2019 · Recall initiated: July 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada.
- Lot
- Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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